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Zimmer Persona Knee Replacement

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The Zimmer Persona Knee System may be used by people suffering from arthritis or knee injuries. Certain components of this system are associated with complications which may necessitate revision surgery and other medical treatment.

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The Zimmer Persona Personalized Knee System is a semiconstrained knee prosthesis that employs modular components between the tibial plates and articular surfaces. 1 Made by Warsaw, Indiana-based Zimmer Inc., the device is intended to resurface the articulating surface of the femoral, tibial and patellar bones. 2

Causes of Knee Pain

This Zimmer knee replacement device is indicated for patients with severe knee pain and disability due to:

Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy

Moderate valgus, varus and flexion deformities

Failed previous surgical attempts to save the knee

Unrepairable flexion instability

Zimmer Knee Replacement Devices

This device is intended for use in either posterior cruciate retaining or sacrificing surgical procedures. It is manufactured in an array of component sizes and shapes. It is advertised as offering multiple constraint options to facilitate component fitting and soft-tissue balancing.

Cruciate-retaining femoral provisionals and components can be used when the posterior cruciate ligament is intact. They can also be used when the posterior cruciate ligament is sacrificed or deficient and removed, provided ultracongruent articular surface provisionals and components also are used.

The device is described as allowing a surgeon to employ a midvastus, subvastus or parapatellar medial arthrotomy approach, with the patella either everted or subluxed.

Problems with Zimmer Persona Metal Tibial Plates

The Zimmer Persona porous coated, uncemented Trabecular Metal Tibial Plate has been subject to a Class II recall due to an increase in complaints of loosening and radiolucent lines. 3

Patients whose Zimmer Persona Knees are affected by these problems may require medical interventions, including potential revision surgery and/or other medical treatment due to loosening. Symptoms may include:

Persistent pain

Loss of mobility

Inflammation

Knee instability

Knee tightness

Tibial Articular Surface Provisional (TASP) Shim Complications

The TASP shim is a surgical tool used by a surgeon during the surgical procedure. It is intended to allow the surgeon to identify the thickness requirements of the knee implant and achieve range of motion for the knee replacement. Use of the instrument has been identified as having issues related to the ball bearings, according to several reports in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.

On January 20, 2014, Zimmer issued an Urgent Medical Device Correction indicating that the TASP shim has the potential to cause delays in surgery and for ball bearings to be left in the surgical wound, believed to be caused by “repeated cycles using sonic cleaning [that] can break down the ball bearing retention feature (swage) on the shim.” The correction and a later February 4, 2015 recall notice goes on to state that these shims “must be manually cleaned and inspected per product insert…”

The recall affects all lots and sizes, C-J Left and Right, of the product’s porous coated, uncemented Trabecular Metal Tibial component. These will no longer be distributed.

Persona Knee Alerts and Warnings

The Zimmer Persona porous coated, uncemented Trabecular Metal Tibial Plate was voluntarily recalled by Zimmer on March 12, 2015, and categorized as a U.S. Food and Drug Administration Class II recall.

The recall affects all lots and sizes, C-J Left and Right, of the product’s porous coated, uncemented Trabecular Metal Tibial component. These will no longer be distributed.

Additionally, at the time of the recall, Zimmer notified doctors, hospitals and distributors – who might be in possession of the affected devices to quarantine them and then complete an Inventory Return Certification form before shipping the recalled units back to the manufacturer.

The Zimmer Persona Tibial Articular Surface Provisional (TASP) Shim tool used in the Zimmer Persona Knee surgery was also subject to a voluntary recall notification on February 4, 2014 after a December 11, 2014 URGENT MEDICAL DEVICE CORRECTION that provided that the TASP shim tool must be manually cleaned and inspected per a new product insert, 87-6203-991-22. The FDA classified that recall as a Class II recall notification. 4

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